- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00582491
Modafinil, Sleep, and Cognition in Cocaine Dependence
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality does not appear to be affected significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest that modafinil reduces the relapse to cocaine use, by unknown mechanisms.
We propose to employ both subjective and objective measures of nocturnal sleep and daytime sleepiness, as well as measures of general cognitive performance and sleep-dependent memory consolidation, to explore potential mechanistic relationships between cocaine abstinence, EDS, and modafinil's efficacy in preventing cocaine relapse.
The following specific aims are proposed:
Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g., reduced total sleep time and sleep efficiency) that progressively characterize periods of sustained cocaine abstinence are also associated with objective evidence of excessive daytime sleepiness (EDS).
Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.
Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether successful abstinence from cocaine is associated with normalization of the same.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06519
- Connecticut Mental Health Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male or female individuals, ages 18-65, meeting current DSM-IV criteria for cocaine dependence. Documented positive urine toxicology screen for cocaine at intake and regular 3 times more weekly use of cocaine.
- Subject has voluntarily given informed consent and signed the informed consent document(s).
- Able to read English and complete study evaluations.
Exclusion Criteria:
- Use of prescription medication in the past 6 months indicating a medical or psychiatric condition that in the opinion of the PI would interfere with study participation (e.g. hypertension, severe renal or hepatic disease, HIV, primary psychotic disorder, primary mood disorder, primary sleep disorder).
- Meeting DSM-IV criteria for dependence on any substance other than cocaine and nicotine.
- Significant underlying medical or psychiatric conditions or hypersensitivity to modafinil that in the opinion of the PI would interfere with study participation.
- Abstinence from cocaine for more than one week prior to inpatient admission.
- Positive urine or serum pregnancy test.
- Women who are pregnant or lactating, or not using a reliable method of birth control.
- (For subjects completing the fMRI portion of the study) Presence of or history indicative of ferromagnetic metal in their bodies.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: I
Modafinil 400mg orally everyday for 16 days
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Modafinil 400mg orally every day for 16 days
Inne nazwy:
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Komparator placebo: II
Placebo orally everyday for 16 days
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Placebo orally everyday for 16 days
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Total Sleep Time (Minutes)
Ramy czasowe: After 1 Week
|
Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. |
After 1 Week
|
Total Sleep Time (Minutes)
Ramy czasowe: After 2 Weeks
|
Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. |
After 2 Weeks
|
Total Sleep Time (Minutes)
Ramy czasowe: After 3 Weeks
|
Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. |
After 3 Weeks
|
Time Spent in Sleep Stage 3 (Minutes)
Ramy czasowe: After 1 Week
|
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16.
Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.
|
After 1 Week
|
Time Spent in Sleep Stage 3 (Minutes)
Ramy czasowe: After 2 Weeks
|
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16.
Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.
|
After 2 Weeks
|
Time Spent in Sleep Stage 3 (Minutes)
Ramy czasowe: After 3 Weeks
|
Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16.
Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.
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After 3 Weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Overall Sleep Quality on Visual Analog Scale (Millimeters)
Ramy czasowe: After 1 Week
|
Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. |
After 1 Week
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Overall Sleep Quality on Visual Analog Scale (Millimeters)
Ramy czasowe: After 2 Weeks
|
Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. |
After 2 Weeks
|
Overall Sleep Quality on Visual Analog Scale (Millimeters)
Ramy czasowe: After 3 Weeks
|
Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. |
After 3 Weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Peter T Morgan, MD, PhD, Yale University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia wywołane chemicznie
- Procesy patologiczne
- Choroby Układu Nerwowego
- Zaburzenia związane z substancjami
- Objawy neurologiczne
- Zaburzenia neurokognitywne
- Choroba
- Zaburzenia snu i czuwania
- Zaburzenia poznawcze
- Zaburzenia związane z kokainą
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Induktory enzymów cytochromu P-450
- Induktory cytochromu P-450 CYP3A
- Stymulatory ośrodkowego układu nerwowego
- Środki promujące czujność
- Modafinil
Inne numery identyfikacyjne badania
- 0607001659
- R01DA011744 (Grant/umowa NIH USA)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Modafinil
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The Cooper Health SystemZakończonyPooperacyjne zaburzenia funkcji poznawczych
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Genuine Research Center, EgyptChemipharm Pharmaceutical Industries, EgyptZakończony
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Jonsson Comprehensive Cancer CenterCephalonZakończonyZmęczenie | Nowotwory mózgu i ośrodkowego układu nerwowego | Efekty poznawcze/funkcjonalneStany Zjednoczone
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VA Palo Alto Health Care SystemZakończonyBezsenność | Zaburzenia inicjacji i utrzymania snu | Choroba AlzheimeraStany Zjednoczone
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California Pacific Medical Center Research InstituteZakończonyUzależnienie od metamfetaminyStany Zjednoczone
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Gary MorrowNational Cancer Institute (NCI)ZakończonyZmęczenie | Nieokreślony guz lity u dorosłych, specyficzny dla protokołuStany Zjednoczone
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California Pacific Medical Center Research InstituteNieznanyUzależnienie od substancji | Uzależnienie od amfetaminyStany Zjednoczone
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University of California, Los AngelesZakończonySchizofrenia | Zaburzenia schizoafektywneStany Zjednoczone
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Technical University of MunichCephalonWycofane